COVID-19 Clinical Trial
Official title:
Topical Antibacterial Agents for Prevention of COVID-19
Verified date | October 2023 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to determine whether intranasal application of aminoglycoside (Neosporin) increases local nasal innate immune responses compared to placebo control in healthy participants.
Status | Completed |
Enrollment | 67 |
Est. completion date | September 22, 2023 |
Est. primary completion date | September 22, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Completion of written informed consent - Covid-negative within 48 hours of enrollment based on PCR or Antigen test. If subjects are found to be positive, the PI will recommend appropriate follow-ups. - In good general health as evidenced by medical history - Ability to take Nasal medication and be willing to adhere to the nasal agent regimen Exclusion Criteria: - Participant with active nasal or respiratory symptoms. - Participant with active or chronic respiratory nasal or respiratory infections and or is currently on antibiotics - Participant who has been treated with oral or topical antibiotics with the past 14 days - Participant who is on intranasal or oral corticosteroids or systemic immunosuppression medication - Participant who has immunocompromised conditions such as rheumatological diseases, HIV, cancer on chemotherapy or biologic therapies. - Participant who is on any intranasally applied medications (prescription or over the counter) including nonmedical nasal products and the use of Netipot or other nasal flush products. - Participant with known allergic history to Neosporin (allergic history to neomycin or bacitracin or polymyxcin or pramoxine or the inactive ingredients that include cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate and white petrolatum) - Participant with known allergies to aminoglycoside antibiotics (neomycin, tobramycin, gentamycin, others) - Participant with history of COVID-19 infection in the past 8 weeks. - Participant who is pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Bill and Melinda Gates Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in in interferon response profile from nasal samples collected measured by a multiplex ELISA assay | Measurement of interferon response from samples collected using a multiplex ELISA to detect which interferon-stimulated genes (ISGs) are present in sample. ISGs measured include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl | From baseline up to Month 1 | |
Primary | Change in in interferon response gene expression profile from nasal samples collected measured by RT-PCR | Measurement of interferon response from samples collected using RT-PCR to detect expression of ISGs. ISGs measured include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl | From baseline up to Month 1 | |
Primary | Change in RNA expression profile of ISGs using RNAseq assay | In a subset of subjects in both arms, RNAseq will be performed to assess the presence and quantity of RNA on samples collected at Day 1 and Day 8. ISGs assessed include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl | Day 1and Day 8 | |
Primary | Change in RNA expression profile of ISGs using single cell RNAseq assay | In a subset of subjects in both arms, single cell RNAseq will be performed to assess the presence and quantity of RNA on single cells from samples collected at Day 1 and Day 8. ISGs assessed include Irf7, Oas1a, Oasl2, Cxcl9, and CxcL10 as well as other corresponding interferons such as Ifna, ifnb, and ifnl | Day 1 and Day 8 |
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